REG - Scancell Hlds - Results for the year ended 30 April 2022
28/10/2022 07:00
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RNS Number : 4300E Scancell Holdings Plc 28 October 2022
28 October 2022
Scancell Holdings plc
("Scancell" or the "Company")
Results for the year ended 30 April 2022
Delivered strong clinical and operational progress from both vaccine and
antibody platforms
Three products in clinical trials
Post-period, signed licensing agreement with Genmab providing strong
commercial validation of the science
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer and infectious disease, today announces its final
audited financial results for the year ended 30 April 2022 as well as a
business update on progress achieved post-period.
Highlights (including post-period):
Vaccines:
· Approval by the UK's MHRA of the clinical trial application (CTA)
for multicentre Modi-1 clinical trial (ModiFY); dosing in Cohort 1 of the
study shown to be safe and three patients recruited to Cohort 2
· Expansion of SCIB1 Phase 2 combination trial (SCOPE) to include
SCIB1 in combination with checkpoint doublet therapy
· Continued development of iSCIB1+ with additional epitopes and
AvidiMab(®) modification to improve potency, utility and patent life of
SCIB1; plan to transition the SCOPE trial to this clinical candidate during
2023
· Recruitment completed in COVIDITY Phase 1 clinical trial in South
Africa, with safety and immunogenicity data expected in Q1 2023, providing
read across to our second-generation ImmunoBody(®) platform
Antibodies:
· All GlyMab(®) anti-glycan monoclonal antibodies (mAbs) successfully
humanised and ready for development
· Post-period, signed licensing agreement with Genmab to develop and
commercialise an anti-glycan mAb, with the Company being eligible to receive
milestone payments of up to $208 million for each product developed and
commercialised, up to a maximum of $624 million if Genmab develops and
commercialises products across all defined modalities. Scancell will also
receive low single digit royalties from Genmab on net sales of all
commercialised products.
· AvidiMab(®) technology has been applied to the Company's internal
programmes to engineer and enhance potency of its anti-glycan antibodies,
ImmunoBody(®) cancer products and COVID-19 vaccine candidates. As well as
these internal programmes which will validate the technology we are also
evaluating how Avidimab(®) can be used to enhance the efficacy of external
antibodies.
Operational and corporate:
· Professor Lindy Durrant, founder, Board Director and Chief
Scientific Officer of Scancell, appointed as Chief Executive Officer of
Scancell Holdings plc in July 2021
· Expanded the Group's R&D capabilities by taking new laboratory
and office space in the Bellhouse Building at The Oxford Science Park
· Dr Richard Goodfellow, Board Director, has decided to retire and not to
stand for re-election at the forthcoming AGM
Financial:
· Operating loss for the 12-month period of £13.3 million (30 April
2021: operating loss: £8.8 million) reflecting the expenditure associated
with the Company's three ongoing clinical trials
· Group cash balance at 30 April 2022 was £28.7million (30 April
2021: £41.1 million)
· Capital structure improved through the extension of the
redemption dates of the outstanding unsecured convertible loan notes (CLNs)
issued by the Company in 2020
Prof Lindy Durrant, Chief Executive Officer, Scancell, commented:
"It has been a year of strong operational and clinical progress for Scancell
with three vaccine candidates now in the clinic and the antibody platforms
gathering momentum with expanded internal research and external validation. We
recently initiated Cohort 2 of the Modi-1 clinical trial, the first candidate
from our Moditope(®) platform, and anticipate reporting early safety and
efficacy data from the ModiFY study in the next 12 months. In addition, we
continue to progress SCOPE for SCIB1 and have completed recruitment in our
COVIDITY Phase 1 trial in South Africa.
"It has also been a transformational period for our antibody technology,
culminating in post-period signing a licensing agreement with Genmab which
provides strong commercial validation of the Company's scientific approach.
Scancell is one of only a few companies globally which has the capability to
produce high affinity, humanised anti-glycan antibodies and the Board remains
excited for what the future holds for this platform.
"We would like to thank shareholders for their continued support in the
Company and look forward to reporting further progress on the development of
our products as we reach several key clinical milestones over the next
financial year."
This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014 (MAR).
For further information, please contact:
Scancell Holdings plc +44 (0) 20 3727 1000
Dr John Chiplin, Executive Chairman
Professor Lindy Durrant, CEO
Stifel Nicolaus Europe Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7710 7600
Nicholas Moore/Samira Essebiyea/William Palmer-Brown (Healthcare Investment
Banking)
Nick Adams/Nick Harland (Corporate Broking)
Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
FTI Consulting +44 (0) 20 3727 1000
Simon Conway/Rob Winder/Alex Davis
About Scancell
Scancell is a clinical stage biopharmaceutical company that is leveraging its
proprietary research, built up over many years of studying the human adaptive
immune system, to generate novel medicines to treat significant unmet needs in
cancer and infectious disease. The Company is building a pipeline of
innovative products by utilising its four technology platforms: Moditope(®)
and ImmunoBody(®) for vaccines and GlyMab(®) and AvidiMab(®) for
antibodies.
Adaptive immune responses include antibodies and T cells (CD4 and CD8), both
of which can recognise damaged or infected cells. In order to destroy such
cancerous or infected cells, Scancell uses either vaccines to induce immune
responses or monoclonal antibodies (mAbs) to redirect immune cells or drugs.
The Company's unique approach is that its innovative products target
modifications of proteins and lipids. For the vaccines (Moditope(®) and
ImmunoBody(®)) this includes citrullination and homocitrullination of
proteins, whereas its mAb portfolio targets glycans or sugars that are added
onto proteins and / or lipids (GlyMab(®)) or enhances the potency of
antibodies and their ability to directly kill tumour cells (AvidiMab(®)).
For further information about Scancell, please visit:
https://www.scancell.co.uk/ (https://www.scancell.co.uk/)
CHAIRMAN'S STATEMENT
I am pleased to report the Group's final results for the year ended 30 April
2022.
During the previous financial year ended 30 April 2021, Scancell raised
significant new funds, amounting to £46.1 million (net proceeds), that have
enabled us to make strong clinical and operational progress during the period,
leveraging our immunology expertise and our proprietary vaccine and antibody
platforms to build our pipeline. During the period, we initiated two clinical
trials with our Modi-1 and COVID-19 vaccines and recruitment is continuing in
the SCIB1 Phase 2 clinical trial. Alongside, preclinical studies have started
to produce and characterise our T cell redirecting bispecific (TCB) antibodies
providing validation of the Company's GlyMab(®) monoclonal antibody (mAb)
platform. Significant progress has also been made in using the AvidiMab(®)
technology in both our own products but also exploring its potential for
enhancing the efficacy of any mAb.
Post-period, we were pleased to announce that the Company has granted Genmab
the worldwide licence to an anti-glycan mAb, providing commercial validation
of our GlyMab(®) platform and R&D skills in utilising this technology to
create novel antibody therapeutics candidates. Under the terms of the
agreement, Genmab made an upfront payment to Scancell and the Company is
eligible to receive milestone payments of up to $208 million for each product
developed and commercialised, up to a maximum of $624 million if Genmab
develops and commercialises products across all defined modalities. Scancell
will also receive single digit royalties from Genmab on net sales of all
commercialised products.
These results could not have been achieved without our staff and I would like
to thank them for their hard work and dedication. In addition, the Board would
like to thank all existing shareholders including Redmile and Vulpes for their
continued support and we look forward to delivering on our plans over the next
12 months and beyond.
Set out below is a summary of progress that has been made across our
innovative and proprietary vaccine and antibody platforms.
VACCINES
Moditope(®) platform
Moditope(®) is a versatile proprietary cancer vaccine platform that targets
stress-induced post-translational modifications (siPTMs) of proteins. This
discovery has allowed the Company to develop a completely new class of potent
and selective therapeutic vaccines. Examples of such modifications include
citrullination, an enzyme-based conversion of arginine to citrulline, and
homocitrullination, in which lysine residues are converted to homocitrulline.
Expression of peptides containing these modifications have been demonstrated
to induce potent CD4 cytotoxic T cells that induce anti-tumour activity
without any associated toxicity.
Modi-1
Modi-1, which targets citrullinated cancer antigens, is the first therapeutic
vaccine candidate to emerge from Scancell's Moditope(®) platform. Modi-1
consists of three citrullinated tumour-associated peptides exploiting the
normal immune response to stressed cells, which is largely mediated by
cytotoxic CD4 T cells. The peptides are linked to AMPLIVANT(®), a potent
adjuvant which, in preclinical models, enhanced the immune response of Modi-1
10-to-100 fold and resulted in highly efficient tumour clearance, including
protection against tumour recurrence. AMPLIVANT(®) is the subject of a
worldwide licensing and collaboration agreement with ISA Pharmaceuticals for
the manufacturing, development and commercialisation of Modi-1.
In August 2021, the Company received approval from the UK's Medicines and
Healthcare products Regulatory Authority (MHRA) for a protocol amendment to
the Phase 1/2 clinical trial ('ModiFY') in patients with solid tumours,
including triple negative breast cancer, ovarian cancer, renal cancer and head
and neck cancer. This amendment was aimed at accelerating patient recruitment
and shortening study timelines. ModiFY is a first-in-human clinical trial and
Modi-1 is being administered alone and in combination with checkpoint
inhibitors (CPIs) in patients where the CPI is standard of care. This open
label study will recruit over 100 patients in up to 20 UK clinical trial sites
and the initial objective is to assess the safety, immunogenicity and efficacy
of the peptides. In addition, the effect of Modi-1 in promoting T-cell
infiltration into the tumour will be assessed in a neoadjuvant cohort in which
a further 30 patients with head and neck cancer will be treated with Modi-1
with or without CPI, prior to their first surgical resection.
In June 2022, the Company announced that the first patient had been dosed in
Cohort 1 of ModiFY and all three patients in the cohort have now received two
doses. The injections were well tolerated with no safety concerns. Three
patients have been recruited to Cohort 2 and are currently receiving higher
doses of the two citrullinated vimentin peptides plus a citrullinated enolase
peptide. The Company expects safety and immunogenicity data to be available
later this year and early efficacy data in 2023.
Modi-2
Modi-2, which targets homocitrullinated cancer antigens, is the second
therapeutic vaccine candidate from the Company's Moditope(®) platform and has
the potential to address different cancer indications to Modi-1, including
tumours with a particularly immunosuppressive environment. Internal
preclinical research and formulation development work has continued to
progress Modi-2 towards the clinic.
ImmunoBody(®) platform
Scancell's ImmunoBody(®) immunotherapy platform uses the body's immune system
to identify, attack and destroy tumours. This is achieved by delivering a DNA
plasmid to enhance the uptake and presentation of cancer antigens to harness
high avidity T cell responses. Each ImmunoBody(®) vaccine can be designed to
target a particular cancer in a highly specific manner, offering the potential
for enhanced efficacy and safety compared with more conventional approaches.
These vaccines have the potential to be used as monotherapy or in combination
with checkpoint inhibitors and other agents. The Directors believe that this
platform has the potential to enhance tumour destruction, prevent disease
recurrence and extend survival.
Scancell's ImmunoBody(®) vaccine approach can also be exploited to induce
immune responses against infectious diseases. As research data emerged at the
beginning of the COVID-19 pandemic, it was clear that the induction of potent
and activated T cells may play a critical role in the development of long-term
immunity and clearance of virus-infected cells. Scancell is therefore also
using its proven cancer vaccine concept to develop a vaccine against
SARS-CoV-2, the virus that causes COVID-19.
SCIB1
SCIB1 is the lead product from the Company's ImmunoBody(®) immunotherapy
platform, which uses the body's immune system to identify, attack and destroy
tumours and is currently being evaluated in a Phase 2 clinical trial ('SCOPE')
in the UK in combination with a checkpoint inhibitor for the treatment of
metastatic melanoma.
Following the approval of a protocol amendment by the MHRA, the trial will
include a cohort of melanoma patients who will receive SCIB1 plus doublet
therapy consisting of ipilimumab (Yervoy(®)) plus nivolumab (Opdivo(®)) in
addition to the cohort who will receive SCIB1 with pembrolizumab
(Keytruda(®)), reflecting changes in the current treatment landscape for
metastatic melanoma patients. The Phase 2 study is designed to assess whether
the addition of SCIB1 treatment to CPI standard of care results in an
improvement in patient outcomes for patients with metastatic disease. The
primary objectives of the trial are tumour response rate, progression-free
survival and overall survival in patients with advanced melanoma.
Under the updated protocol the Company will also test the SCIB1 vaccine
delivered via needle-free injection, using a PharmaJet(®) device. Prior to
the amendment, SCIB1 has been delivered using electroporation to enhance the
uptake and presentation of the DNA vaccine to the immune system and, although
electroporation is a proven delivery method, the Company believes that
needle-free injection could provide enhanced patient acceptance.
iSCIB1+
The Company has also been developing iSCIB1+, an AvidiMab(®) modified version
of SCIB1, which is expected to increase both the potency of SCIB1 and extend
patent life. This modification also includes multiple epitopes so it can be
used to treat all patients rather than be limited to the 40% of patients who
have the appropriate HLA type for treatment with SCIB1. Given the significant
improvements in potency, utility and patent life with iSCIB1+, the Company
plans to transition the SCOPE trial to the iSCIB1+ product during 2023.
COVIDITY
The COVIDITY programme, focusing on the Company's novel COVID-19 vaccine
candidates SCOV1 and SCOV2, recently completed recruitment in South Africa and
will report safety and immunogenicity data in Q1 2023. Given the large size of
later stage trials, the Company intends to partner this programme once it has
generated proof of concept data from the Phase 1 trial. The Company is also
using PharmaJet(®) needle-free injection systems in this trial as well as in
the SCOPE trial of SCIB1.
ANTIBODIES
GlyMab(®) platform
The GlyMab(®) platform provides a powerful and versatile approach to
generating novel antibody drug candidates for our own clinical pipeline but
also to partner with other companies in areas such as drug targeting to
capitalise on other groups' expertise. The GlyMab(®) antibodies bind to sugar
motifs, rather than peptide epitopes, found on the surface of glycosylated
proteins and lipids that are implicated as drug targets in particular cancers
and potentially other diseases. As such, this novel proprietary platform
expands on the Company's innovative approach to developing innovative
therapies for cancer and infectious disease. The Company currently has a
pipeline of five anti-glycan mAbs: SC129, SC134, SC88 and SC27 that target
solid tumours including pancreatic, small cell lung, colorectal and gastric
cancers, and SC2811 that targets a glycolipid present on T cells. All of these
drug candidates have now been successfully humanised and are ready for the
next stage of development.
The Company will develop GlyMab(®) antibodies into redirecting TCB antibodies
and take them into the clinic. This is a promising new therapeutic approach
for treating cancer. TCB antibodies have dual-binding specificity which
crosslinks tumour cells via their glycans with an activating receptor CD3 on T
cells. This results in activation of killer T cells and tumour cell death.
These antibodies are particularly potent in tumours which have lost the T cell
recognition molecule major histocompatibility antigen (MHC) or where there is
limited T cell infiltration as they by-pass normal T cell activation pathways
and redirect the host immune system to the tumour.
To create TCB antibodies, Scancell will combine its proprietary GlyMab(®)
antibodies, which target sugar motifs rather than proteins and are designed to
have superior affinity and selectivity profiles, with in-licenced Fc silencing
technology from Oxford-based mAbsolve. The technology from mAbsolve reduces
the likelihood of toxicity caused by cytokine storms, which can be associated
with clinical antibodies engaging the immune system. Scancell will leverage
its deep understanding of cancer immunotherapy and T cell immunology together
with its strong development capabilities to bring the TCB antibodies to
clinical validation, thereby adding value to the entire GlyMab(®) platform.
Currently the Company is in the preclinical research phase and expects to take
a novel product into a Phase 1 clinical study in due course. The first two
mAbs to move into clinical development in-house are anticipated to be a
redirected TCB and an ultra-specific T cell costimulatory mAb which the Board
believe will validate the commercial value of the entire GlyMab(®) antibody
platform.
Post-period, the Company announced a licensing agreement with Genmab to
develop and commercialise Scancell's anti-glycan mAb. The Company is eligible
to receive milestone payments of up to $208 million for each product developed
and commercialised, up to a maximum of $624 million if Genmab develops and
commercialises products across all defined modalities. Scancell will also
receive low single digit royalties from Genmab on net sales of all
commercialised products
AvidiMab(®) platform
AvidiMab(®) is a versatile platform technology that can enhance the avidity
and thereby the potency of any antibody. To date, the Company has used
AvidiMab(®) in its internal programmes to:
· Engineer the anti-glycan mAbs to improve their ability to
directly kill tumour cells.
· Engineer other mAbs to enhance their potency and/or extend their
patent lifetime.
· Increase the breadth of response and potency of Scancell's
ImmunoBody(®) cancer products.
· Increase the potency of the T cell response in Scancell's
COVID-19 vaccine which in turn should lead to improvements in long-term
protection and immunological memory.
Post-period, Scancell recently presented preclinical data on its antibody
platforms at the EuroMAbNet 12(th) Annual Meeting which illustrated the
versatility and specificity of the Company's platforms in generating novel
antibody drug candidates using its GlyMab(®) technology and enhancing their
anti-cancer potential with AvidiMab(®).
Looking forward, Scancell is planning to increase the value of this rich
pipeline of products through the generation of early-stage clinical data,
either alone or in combination with strategic partners.
CORPORATE
Directors
During July 2021, Professor Lindy Durrant, founder, Board Director and Chief
Scientific Officer of the Group was appointed as Chief Executive Officer of
Scancell Holdings plc, following Dr Cliff Holloway's decision to step down as
a Board Director and CEO. The Board firmly believes that her strategic
insight, commitment to the Company and strong leadership skills will deliver
significant value to the business and shareholders.
Dr Richard Goodfellow has been a Director at Scancell since 1999 and, after
many years' service, has decided not to stand for re-election at the
forthcoming Annual General Meeting (AGM) and retire. Richard was Chief
Executive Officer of the Group until 2017 and since then has been extremely
supportive to me and the rest of the Board. On behalf of the Board, I would
like to thank Richard for his invaluable contribution to the growth of
Scancell and wish him well in his retirement.
New office and additional laboratory facilities
In August 2021 Scancell entered into a five-year lease agreement with The
Oxford Science Park for additional laboratory and office space in the
Bellhouse Building at the Oxford Science Park. These new premises, which are
complementary to Scancell's laboratories in the Biodiscovery Institute at the
University of Nottingham, will allow the Company to further accelerate the
development of its portfolio of immunotherapies.
FINANCIAL REVIEW
Profit or Loss and Other Comprehensive Income Statement
The Group made an operating loss for the year to 30 April 2022 of £13.3
million (2021 loss of £8.8 million).
The increase in development expenditure to £9.5 million (2021: £6.4 million)
relates to the average number of research staff increasing to 33 (2021: 21)
and increased costs on all research projects as the Company now has sufficient
resources to work on the existing Moditope(®) and ImmunoBody(®) platforms
and also the GlyMab(®) and AvidiMab(®) platforms.
Administrative expenditure has increased to £4.8 million (2021: £3.3
million) reflecting amortisation charges arising from the additional office
and laboratory space leased on the Oxford Science Park, a share option charge
and increased salary costs as non-research employee numbers increased to seven
from four.
During the period, the Company received grant income of £1.0 million (2021:
£0.9 million) from Innovate UK, the UK's Innovation Agency, which has
partially funded the development of the COVID-19 vaccine and COVIDITY
programme.
Interest payable of £2.9 million (2021: £1.7 million) largely relates to the
interest on the convertible loan notes (CLNs) which were issued in November
2020. The interest charge for the current year represents a full year's
charge.
The finance credit of £5.2 million (2021: expense £6.32 million) relating to
the derivative liability is the fair value adjustment of the derivative
liability at 30 April 2022. The finance expense is not a cash item and has no
impact upon the Company's cashflow.
The gain on the substantial modification of the CLNs amounting to £7.2
million (2021: £nil) arises from accounting adjustments from the replacement
of the CLNs in existence at 27 October 2021 with new CLNs with a later
maturity data. These adjustments have no impact upon Scancell's cashflows.
The Loss before taxation amounted to £3.8 million (2021: £16.8 million) and
the R&D tax credit increased slightly to £1.7 million (2021: £1.3
million). As the Company has received grant income in respect of the
development of the COVIDITY vaccine, none of the COVIDITY development costs
can be included in the R&D tax claim.
Overall, the loss for the year was £2.1 million (2021: loss £15.5 million).
Statement of Financial Position
At 30 April 2022, the net assets of the Group amounted to £18.1 million
(2021: £19.5 million) including cash at bank of £28.7 million (2021: £41.1
million).
The new lease for the Bellhouse Building in Oxford was recognised as a right
of use asset and a lease liability increasing additions to the right of use
asset and the lease liability by £1.2 million. Additions to fixed assets in
the year amounted to £1.3 million of which £0.8 million related to
laboratory equipment.
The tax receivable due at the end of the year amounted to £3.0 million (2020:
£1.3 million) and relates to the R&D tax credit for the 2020/21 tax year
plus the tax credit for the year to 30 April 2022.
The fall in Trade and other receivables to £647k (2021: £968k) is partly due
to the Innovate UK grant finishing at 31 March 2022 and the Company being
restricted in the amount of expenditure it could claim back.
On 27 October 2021, the Company announced that it had entered into a Deed of
Amendment (Deed) relating to the extension of the redemption dates for the
CLNs and under the Deed, the redemption date for the August 2020 CLNs was
extended to 12 August 2025 and for the November 2020 CLNs was extended to 10
November 2025. The CLNs are required to be redeemed on the new redemption
dates if they have not previously been converted into ordinary shares in the
Company.
The Derivative Liabilities represents the fair value of the conversion feature
of the CLNs at the time of issue of the CLNs with changes in value being shown
in the Consolidated Profit or Loss and Other Comprehensive Income Statement as
a finance credit or expense.
Consolidated Cash Flow Statement
As at 30 April 2022, bank balances amounted to £28.73 million (2021: £41.1
million). As can be seen in the Consolidated Cash Flow Statement, there has
been a decrease in cash and cash equivalents of £12.4 million (2021: increase
£37.5 million). The Company has been able to progress on all platforms with
the cash used for this being £11.5 million (2021: £7.8 million), purchase of
fixed assets amounting to £1.3 million (2021: £0.7 million), payment of
interest on the Convertible Loan Notes of £537k (£2021: £nil) and the new
lease agreement for the offices and laboratories in Oxford has increased lease
payments in the year to £391k (2021: £154k).
OUTLOOK
Over the past 12 months, Scancell has made good progress with three vaccine
candidates now in the clinic and preclinical activities moving the antibody
platforms forward, building on our expertise in immunology to underpin and
drive our dual approach to targeting modified neo-antigens for cancer therapy.
Looking forward, we anticipate that key milestones will be achieved in the
next financial year with safety and efficacy readouts from all three of our
current vaccine clinical trials:
· Recruitment of patients in the ModiFY trial is progressing well with
seven active clinical sites; early safety and efficacy data due to be reported
in the next 12 months.
· Recruitment of melanoma patients into the current SCOPE trial is also
ongoing; the Company aims to transition iSCIB1+ into this study during 2023 to
expand the patient population and extend the patent life of the product.
· Our COVIDITY trial has completed recruitment in South Africa and the
Company intends to partner this programme once the proof-of-concept data from
the Phase 1 trial has been collated and reviewed providing validation of the
utility of our ImmunoBody(®) technology in treating infectious diseases.
In addition, product development has been initiated for Modi-2, the second
vaccine from the Moditope(®) platform, and the Company expects to start GMP
manufacturing and nonclinical toxicity studies within the current financial
year, with a view to starting a Phase 1/2 clinical trial in the 2023/2024
financial year.
Scancell is one of only a few companies worldwide that has the capability to
produce high affinity, humanised anti-glycan antibodies and we now have a
strong portfolio of patent-protected mAbs with excellent specificity and which
bind strongly to tumour tissues. The recent licensing deal with Genmab, with
milestones of up to $624 million and single digit royalties, provides
commercial validation of this antibody portfolio. Each mAb can be developed
into multiple products which presents a rich reservoir of potential products
for in house development and also for further revenue-generating deals with
third parties. The first two mAbs to be taken into clinical development in
house are anticipated to be a redirected TCB and an ultra-specific T cell
costimulatory mAb.
The Company's current GlyMab(®) technology generates highly selective murine
mAbs, which are subsequently humanised. This platform is now being
complemented by a new discovery research technology that enables us to produce
fully-human mAbs directly from human blood. Scancell will use both of these
methods to further generate, characterise and develop novel anti-glycan mAbs.
Furthermore, the Company is applying its AvidiMab(®) modifications to
commercially available mAbs to improve their therapeutic indices and efficacy
profiles.
Scancell continues to progress its goal to build a sustainable company turning
science into world leading vaccines and antibodies targeting
post-translational modifications, and so improving both patient outcome and
shareholder value.
John Chiplin
Chairman
CONSOLIDATED PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME STATEMENT for the
year ended 30 April 2022
2022 2021
Notes £'000 £'000
Development expenses (9,477) (6,406)
Administrative expenses (4,787) (3,346)
Grant income 965 918
OPERATING LOSS 2 (13,299) (8,834)
Interest receivable and similar income 4 3
Interest payable (2,882) (1,651)
Gain on substantial modification of convertible loan notes 7,166 -
Finance expense relating to derivative liability 5,243 (6,323)
LOSS BEFORE TAXATION (3,768) (16,805)
Taxation 3 1,703 1,328
LOSS FOR THE YEAR AND TOTAL COMPREHENSIVE LOSS (2,065) (15,477)
LOSS PER ORDINARY SHARE
(pence)
4
Continuing
Basic (0.25)p (2.28)p
Diluted (0.25)p (2.28)p
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended 30 April 2022
Share Share Share Retained
Capital Premium Option losses Total
£'000 £'000 £'000 £'000 £'000
Balance 1st May 2020 465 38,388 372 (31,577) 7,648
Share issue 280 23,856 - - 24,136
Expenses of issue - (1,409) - - (1,409)
Conversion of loan notes 70 4,184 - 4,254
Share option credit - - 333 - 333
Loss for the year and other comprehensive loss (15,477) (15,477)
Balance 30 April 2021 815 65,019 705 (47,054) 19,485
Loss for the year and other comprehensive loss - - - (2,065) (2,065)
Share option credit - - 690 - 690
Balance 30 April 2022 815 65,019 1,395 (49,119) 18,110
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
as at 30 April 2022
2022 2021
£'000 £'000
ASSETS
Non-current assets
Tangible fixed assets 1,579 692
Right-of-use assets 1,165 283
Goodwill 3,415 3,415
6,159 4,390
Current assets
Trade and other receivables 647 968
Income tax assets 2,990 2,590
Cash and cash equivalents 28,725 41,110
32,362 44,668
TOTAL ASSETS 38,521 49,058
LIABILITIES
Non-current liabilities
Convertible Loan note (7,008) (15,184)
Derivative liability (10,095) (12,031)
Lease liabilities (856) (63)
(17,959) (27,278)
Current liabilities
Trade and other payables (2,137) (2,087)
Lease liabilities (315) (208)
(2,452) (2,295)
TOTAL LIABILITIES (20,411)) (29,573)
NET ASSETS 18,110 19,485
TOTAL EQUITY
Called up share capital 815 815
Share premium account 65,019 65,019
Share option reserve 1,395 705
Retained earnings (49,119) (47,054)
18,110 19,485
CONSOLIDATED CASH FLOW STATEMENT
for the year ended 30 April 2022
2022 2021
£'000 £'000
Cash flows from operating activities
(Loss) before tax (3,768) (16,805)
Adjustments for:
Finance income (4) (3)
Lease interest paid 48 12
Convertible loan interest payable 2,834 1,639
Finance expense for derivative liability (5,243) 6,323
Gain on substantial modification of convertible loan notes (7,166) -
Depreciation 381 115
Amortisation of right-of-use asset 359 134
Share-based payment charge/ (credit) 690 333
Cash used in operations before changes in working capital (11,869) (8,252)
(Increase)/Decrease in other receivables 321 (597)
Increase /(Decrease) in accounts and other payables 51 1,046
Cash used in operations (11,497) (7,803)
Tax credits received 1,304 -
Net cash used in operating activities (10,193) (7,803)
Investing activities
Purchase of tangible fixed assets (1,268) (744)
Finance income 4 3
Net cash (used in) investing activities (1,264) (741)
Financing activities
Proceeds from issue of share capital - 24,136
Expenses of share issue - (1,409)
Proceeds from issue of convertible loan notes - 23,901
Expenses of convertible loan notes issue - (395)
Convertible loan interest paid (537) -
Lease payments (27) - (391) (154)
Net cash generated from financing activities (928) 46,079
Net (decrease)/increase in cash and cash equivalents (12,385) 37,535
Cash and cash equivalents at beginning of the year 41,110 3,575
Cash and cash equivalents at end of the year 28,725 41,110
(391)
(154)
Net cash generated from financing activities
(928)
46,079
Net (decrease)/increase in cash and cash equivalents
(12,385)
37,535
Cash and cash equivalents at beginning of the year
41,110
3,575
Cash and cash equivalents at end of the year
28,725
41,110
NOTES TO THE FINANCIAL INFORMATION
for the year ended 30 April 2022
1 BASIS OF PREPARATION
These financial results do not comprise statutory accounts for the year ended
30 April 2022 within the meaning of Section 434 of the Companies Act 2006. The
financial information in this announcement has been extracted from the audited
financial statements for the year ended 30 April 2022. The auditors reported
on those accounts and their report (i) was unqualified; (ii) did not include
references to any matters to which the auditors drew attention by way of
emphasis without qualifying their report and (iii) did not contain statements
under section 498 (2) or (3) of the Companies Act 2006. The statutory accounts
for the year ended 30 April 2022 have not yet been delivered to the Registrar
of Companies.
The financial statements have been prepared on the going concern basis on the
grounds that the directors have reviewed the funding available and the group's
cash flow forecast and are content that sufficient resources are available to
enable the group to continue in operation for at least twelve months from the
date of approval of these financial statements.
These financial statements have been prepared in accordance with UK adopted
international accounting standards in applicable to companies reporting under
IFRS. Assets and liabilities are initially recognised at historical cost or
transaction value unless otherwise stated in the relevant accounting policies.
2 OPERATING LOSS
2022 2021
£'000 £'000
Operating Loss is stated after charging/(crediting):
Grant income (965) (918)
Depreciation on tangible fixed assets 381 115
Amortisation of right-of-use asset 360 134
Research and development 9,477 6,406
Auditors' remuneration - fee payable for audit of the company 32 25
Auditors' remuneration - fee payable for audit of the subsidiary company 32 22
Auditors remuneration - non -audit serrvices 8 4
Directors' remuneration 1,185 1,015
3 TAXATION
The tax credit on the loss on ordinary activities for the year was as follows:
2022 2021
Current tax £'000 £'000
UK corporation tax credits due on R&D expenditure 1,754 1,288
Adjustment to prior year (51) 40
1,703 1,328
Factors affecting the tax credit
The tax assessed for the years is lower than the applicable rate of
corporation tax in the UK. The difference is explained below:
2022 2021
£'000 £'000
Loss on ordinary activities before tax (3,768) (16,805)
(716) (3,193)
Loss on ordinary activities multiplied by the small company rate of tax in the
UK (19 %)
Effects of:
Disallowed (income)/ expenditure on convertible loans (1,820) 1,632
Other disallowed expenditure 131 94
Other timing differences 23 17
Enhanced tax relief on R&D expenditure (1,329) (967)
Reduced tax relief for losses surrendered for R&D tax credits 557 396
Prior year (under)/ over provision 51 (40)
Unrelieved losses carried forward 1,400 827
Current tax (credit) (1,703) (1,328)
The Group has tax losses to carry forward against future profits of
approximately £35.22 million (2021: £26.65 million).
A deferred tax asset has not been recognised in respect of these losses as the
Group does not anticipate sufficient taxable profits to arise in the
foreseeable future to fully utilise them.
The estimated value of the deferred tax asset not recognised measured at the
prevailing rate of tax when the timing differences are expected to reverse is
£8.4 million (2021: £4.9 million). This is based on the substantively
enacted rates at the balance sheet date. The current UK corporation rate of
19% was set to increase to 25% from 1 April 2023, as set out in the Finance
Bill 2021 which was substantively enacted on 24 May 2021. Although it has
recently been announced that this increase will not go ahead, as this has not
been substantively enacted, the deferred tax balances are still measured at
25% (2021: 19%)
Taxation receivable is £2,990,000 (2021: £2,590,000).
4 LOSS PER SHARE
Basic loss per share
The earnings and weighted average number of ordinary shares used in the
calculation of basic loss per share is as follows:
2022 2021
£'000 £'000
Loss used in calculation of basic loss per share (2,065) (15,477)
Number Number
Weighted average number of ordinary shares of 0.1p each for the calculation of
basic loss per share
815,218,831 678,628,780
Diluted loss per share
As the Group is reporting a loss from continuing operations for both years
then, consequentially, the share options are not considered dilutive because
the exercise of the share options would have the effect of reducing the loss
per share.
At the year end the issued share capital amounted to 815,218,831 ordinary
shares.
5 DELIVERY OF ACCOUNTS
The audited statutory accounts in respect of the prior year ended 30 April 2021 have been delivered to the Registrar of Companies. The auditors issued an unqualified audit opinion which did not contain any statement under section 498(2) or 498(3) of the Companies Act 2006.
6 AVAILABILITY OF ACCOUNTS
This announcement is not being posted to shareholders. Copies of this announcement can be downloaded from the Company's website:
www.scancell.co.uk (http://www.scancell.co.uk)
together with copies of the Report and Accounts.
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